Axonyx Initiates Beta-Amyloid Clinical Trial with Phenserine for Alzheimer's Disease.Business Editors/Health/Medical Writers NEW YORK--(BUSINESS WIRE)--June 2, 2003 Axonyx Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : AXYX) today announced the initiation of the first trial in its planned Phase IIb/Phase III clinical program for Phenserine. Regulatory and Local Ethical Committee approvals in the U.K. have been received and patients will now be recruited into the Company's beta-amyloid Phase IIb clinical trial. This randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. placebo-controlled double-blind trial will evaluate Phenserine's ability to lower the levels of the beta-amyloid precursor protein (beta-APP) and beta-amyloid in the plasma and cerebrospinal fluid cerebrospinal fluid (CSF) Clear, colourless liquid that surrounds the brain and spinal cord and fills the spaces in them. It helps support the brain, acts as a lubricant, maintains pressure in the skull, and cushions shocks. of mild to moderate Alzheimer's disease Alzheimer's disease (ăls`hī'mərz, ôls–), degenerative disease of nerve cells in the cerebral cortex that leads to atrophy of the brain and senile dementia. (AD) patients. Patients in this trial will also undergo testing with the standard memory and cognition tests, the ADAS-cog and CIBIC-plus efficacy endpoints, recommended by the United States FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. and European regulatory authorities. Phenserine is an acetylcholinesterase- and beta-APP-inhibitor that has previously been shown to be safe and efficacious in improving memory in a 12-week study in mild to moderate AD patients. The objective of this clinical trial is to substantiate previously published in vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment. in vi·tro adj. In an artificial environment outside a living organism. and in vivo in vivo /in vi·vo/ (ve´vo) [L.] within the living body. in vi·vo adj. Within a living organism. in vivo adv. preclinical data that has consistently shown that Phenserine can reduce the levels of beta-APP and beta-amyloid. The presence of toxic beta-amyloid in the brains of Alzheimer's disease patients is considered by many experts to be a key pathologic event in the causation as well as the progression of AD. "The data from this trial has the potential to differentiate Phenserine from other approved and marketed AD drugs in its class, which currently generate revenues in excess of $1.5 billion worldwide," stated Gosse B. Bruinsma, M.D., Chief Operating Officer Chief Operating Officer (COO) The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president. of Axonyx. About Axonyx Axonyx Inc. is a U.S.-based biopharmaceutical company engaged in the acquisition and development of proprietary pharmaceutical compounds and new technologies useful in the diagnosis and treatment of Alzheimer's disease, human memory disorders and prion-based illnesses such as Mad Cow Disease mad cow disease: see prion. mad cow disease or bovine spongiform encephalopathy (BSE) Fatal neurodegenerative disease of cattle. Symptoms include behavioral changes (e.g. . This press release may contain forward-looking statements or predictions. These statements represent our judgment to date, and are subject to risks and uncertainties that could materially affect the Company including those risks and uncertainties described in the documents Axonyx files from time to time with the SEC, specifically Axonyx's annual report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. . Axonyx cannot assure that the Phase IIb clinical trial, or others, if any, with Phenserine will prove successful, that the safety and efficacy profile of Phenserine exhibited in the previous small Phase II trial will remain the same in the Phase IIb clinical trial, or future clinical trials, if any, that the preclinical results related to the regulation of beta-APP will be substantiated by the Phenserine Phase IIb clinical trial and that Phenserine will be able to slow the progression of Alzheimer's disease ,that the Phase IIb clinical trial data will differentiate Phenserine from the currently marketed drugs, that Axonyx will obtain the necessary financing to complete any Phase III Phenserine trials, that the efficacy data from the Phase IIb clinical trial will be able to be used with any Phase III efficacy data, that the FDA will approve the protocol for a Phase III trial, that the Company's development work on Phenserine will support an NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any filing, that the results of the Phase III trials will allow Phenserine to be approved by the FDA, that the FDA will grant marketing approval for Phenserine, that if Phenserine is approved by the FDA, it will prove competitive in the market, and that Axonyx will obtain licensing or corporate partnership agreements that will enable acceleration of the development of and optimize marketing opportunities for, Phenserine, or that Axonyx will be able to advance any other potential memory enhancing compound toward IND status. Axonyx undertakes no obligation to publicly release the result of any revisions to such forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. |
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